Kornimate/medical-research-clean huggingface dataset:
human mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: this study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (huc-mscs) in children with moderate and severe bronchopulmonary dysplasia.

bronchopulmonary dysplasia (bpd) is one of the most common chronic lung diseases with poor prognosis, especially in preterm infants with moderate and severe bpd. however, there is lack of effective therapies for this disease. huc-mscs are widely used in clinic due to their low immunogenicity and convenient to get.many animal study had shown that huc-mscs had therapeutic effects on a variety of animal models of lung disease.furthermore,there are a large number of clinical trials of mscs applied to various system diseases and the safety was verified.so,the main purpose of this study is to evaluate the safety and efficacy of huc-mscs in participants with moderate and severe bronchopulmonary dysplasia.

Eligibility criteria:
inclusion criteria: 1. participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy 2. the legal representative or the participant had signed consent. exclusion criteria: * 1. severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, iii-iv grade pulmonary hypertension, lung transplantation, current indications of acute surgery after lung transplantation) 2. participants whose age is more than 1 year old.

Keywords: human umbilical cord -derived mesenchymal stem cells moderate and severe bronchopulmonary dysplasia
using dichoptic therapy to treat intermittent exotropia

Conditions: Exotropia Intermittent

Summary: intermittent exotropia is difficult to treat. the mainstay of treatment involves surgery, and in one long-term study authors found that as many as 60% of ixt required at least one re-operation.patching of the non-dominant eye has also been tested in a large, multi-center randomized control trial and was not found to have a large benefit. more non-surgical treatment modalities are critical to improve the care in this condition.

luminopia, a dichoptic therapy device, was approved by the fda in 2021 for use in amblyopia in children aged 4-7 years. the device was shown to improve vision in the amblyopic eye by lines in three months of use. patients with strabismic amblyopia were also enrolled in the trial and found to have similar gains in vision in the amblyopic eye. li et al. used an investigational dichoptic therapy device in patients with intermittent exotropia and had a statistically significant improvement in ocular alignment as measured in prism diopters.the dichoptic therapy this study used is not commercially available, therefore using luminopia to study this population may result in an immediately available non-surgical treatment for intermittent exotropia patients.

Eligibility criteria:
inclusion criteria: * diagnosed with ixt * one eye that is their preferred eye * ages 4-7 * distance control scores of \<= 4 exclusion criteria: * distance control scores of 5 * patients with visual acuity with vision that is worse in one eye by greater than two lines * no preferred eye * patients who would be unable to tolerate wearing the headset for 1 hour/day, 6 days/week, for 12 weeks.

Keywords: dichoptic therapy
a dose escalation/expansion study of ldk378 in patients with tumors characterized by genetic abnormalities in anaplastic lymphoma kinase

Conditions: Tumors Characterized by Genetic Abnormalities of ALK

Summary: this study assessed the safety and efficacy of ldk378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (alk).


Eligibility criteria:
inclusion criteria: * ecog performance status of ≤ 2 and life expectancy of ≥ 12 weeks. * diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists. only patients with tumors characterized by genetic abnormalities in alk were enrolled. * for nsclc, an alk translocation must be detected by fish in ≥ 15% of tumor cells. * in patients with diseases other than nsclc, alk translocation is not required and overexpression of alk protein may be considered indicative of a genetic abnormality in alk. * patients with measurable or non-measurable disease as determined by modified recist version 1.0 in dose-escalation phase, and patients with at least one measurable lesion as determined by recist 1.0 in expansion phase. exclusion criteria: * patients with symptomatic central nervous system (cns) metastases who were neurologically unstable or required increasing doses of steroids to control their cns disease were excluded. * patients with a prior or current history of a second malignancy, impaired gi function, history of pancreatitis or increased amylase or lipase, known diagnosis of hiv, and clinically significant cardiac disease were excluded. * patients treated with chemotherapy or biologic therapy or other investigational agent \< 2 weeks prior to starting study drug for compounds with a half-life ≤ 3 days, and \< 4 weeks prior to starting study drug for compounds with a prolonged half-life were excluded. * further, patients treated with medications that were known to be strong inhibitors or inducers of cyp3a4/5 that could not be discontinued at least a week prior to start of treatment with ldk378 and for the duration of the study were also excluded. other protocol-defined inclusion/exclusion criteria may apply

Keywords: alk inhibitor, nsclc, ldk378, ceritinib, genetic abnormalities
the impact of chewing gum on postoperative bowel activity and postoperative pain after total laparoscopic hysterectomy

Conditions: Postoperative Pain

Summary: surgical interventions, such as restoring the health of patients and eliminating their existing symptoms, the surgical process can have many negative effects on the patient. in order to minimize these complications, the accelerated recovery protocol after surgery (eras) has also found widespread use in obstetric surgery. the eras protocol consists of different evidence-based practices at each stage, before, during, and after surgery. stool and gas extraction, especially colorectal reported that chewing gum has a positive impact on the time/ can be used after pelvic surgical procedures, perioperative care guide contains reported in eras protocols, evidence-based, inexpensive, easily applied, and easily tolerated a practice that is emphasized.

surgical interventions, such as restoring the health of patients and eliminating their existing symptoms, the surgical process can have many negative effects on the patient. in order to minimize these complications, the accelerated recovery protocol after surgery (eras) has also found widespread use in obstetric surgery. the eras protocol consists of different evidence-based practices at each stage, before, during, and after surgery. stool and gas extraction, especially colorectal reported that chewing gum has a positive impact on the time/ can be used after pelvic surgical procedures, perioperative care guide contains reported in eras protocols, evidence-based, inexpensive, easily applied, and easily tolerated a practice that is emphasized. different studies have been conducted to determine the effect of chewing gum on intestinal peristalsis. intestinal sounds and defecation of chewing gum after cesarean section surgery. a limited number of studies on patients with total laparoscopic hysterectomy exist on this topic.

Eligibility criteria:
inclusion criteria: * total laparoscopic hysterectomy is the most common type of hysterectomy., * who is literate, * over 18 years old, * the body mass index is dec 18.50-24.99 kg/m2, * able to communicate, no language problems. * no history of allergies, * who volunteered to participate in the study and received my approval, * no complications during the operation, * with a patient who is not diagnosed with a mental and psychiatric illness exclusion criteria: * who can not adapt to the treatment process, * developing postoperative complications, * chemotherapy - receiving radiation therapy therapy, * with epilepsy disease, * with any history of allergies, * a history of dental and gum diseases, with difficulty chewing, * with a problem of the mucous membrane inside the mouth, * using drugs that can affect bowel function due to systemic diseases, * patients with a mental disability or a perception problem

Keywords: pain total laparoscopic hysterectomy surgery bowel functions chewing gum nursing
ccc project- acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: to develop and implement quality improvement programs for the treatment of acute coronary syndrome (acs) in china based on the successful experience of the aha-get with the guidelines program. this program will use data collection, analysis, feedback, and process improvement to extend the use of evidence-based guidelines throughout the healthcare system and improve patient care of acute coronary syndrome.


Eligibility criteria:
inclusion criteria: hospitalized patients with discharge diagnosis as acute coronary syndrome (including stemi, nstemi and uap) in 150 tertiary and 100 secondary hospitals. exclusion criteria: none
electronic repositioning with acuity and easytrak leads

Conditions: Heart Failure

Summary: evaluate appropriate performance of electronic repositioning™ (er) in the clinical routine, cumulative incidence of phrenic nerve stimulation (pns) \& success rates of electronic repositioning (er) to remove it, various incl. left ventricular pacing (lvp) thresholds and pns

bipolar leads for left ventricular pacing (lvp) such as the newly available acuity™ or the standard easytrak™ ii and easytrak™ iii leads from guidant in combination with suitable devices for cardiac resynchronization therapy (crt) allow for the non-invasive programming of different left ventricular pacing (lvp) configurations. hence, this electronic repositioning (er) may help physicians to overcome problems in cardiac resynchronization therapy (crt) such as ineffective biventricular pacing, high left ventricular pacing (lvp) thresholds and phrenic nerve stimulation (pns) without the need for an additional patient's operation to reposition lv leads. the erace study it a multi-center, prospective, non-randomized clinical study to document and evaluate appropriate performance of guidant's electronic repositioning™ in the clinical routine with respect to the following major aspects: avoidance of pns and low lvp thresholds (for low battery consumption and extended device longevity) in standard cardiac resynchronization therapy (crt)

Eligibility criteria:
inclusion criteria: * patients receiving their first implantation of a left ventricular (lv) lead in combination with a crt device with implantable cardioverter defibrillator (icd) backup and the possibility for electronic repositioning™ * patients willing (= signed written consent) and capable to participate in all procedures of the study" exclusion criteria: * patients who will not be available for routine follow up * 18 years old * known pregnancy.
20101299: study to evaluate the effect of amg 747 on schizophrenia negative symptoms

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effect of amg 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. after a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.


Eligibility criteria:
inclusion criteria: * diagnosis of diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) schizophrenia * total score on the panss marder negative symptom factor scale (nsfs) ≥20 * total score on the panss marder positive symptom factor scale (psfs) ≤ 30 * receiving stable antipsychotic therapy for at least 8 weeks prior to screening * receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening * subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study * the subject or subject's legally acceptable representative has provided informed consent. exclusion criteria: * current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid iq ≤ 70 * clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam * substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening * substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening * planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study * positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines). * other criteria may apply

Keywords: schizophrenia negative symptoms
adults in the making prevention trial

Conditions: Alcohol Drinking

Summary: this study was a randomized prevention trial investigating the efficacy of the adults in the making (aim) prevention program against a control condition. the primary outcome variable is alcohol use. the study sample were 367 african american seniors in high school and their primary caregivers. the aim program is a 6 session (12 hour) family-centered intervention designed to deter alcohol use.

the study investigators designed a multicomponent prevention program to deter substance use among african american emerging adults in rural georgia (saaf-emerging adult program, saaf-eap). the intervention's delivery is modeled after an existing prevention program designed by dr. brody called, the strong african american families (saaf) program and included a series of separate weekly sessions for emerging adults, their parents, and extended family members, as well as sessions in which participants interact with one another to apply the skills learned in the separate sessions. the sample consisted of 690 families with a high school senior, half of whom will be assigned randomly to a prevention group and half of whom will be assigned to a control group. pre-intervention, post-intervention, and follow-up assessments of emerging adults' substance use were conducted with the entire sample. the study started when the participants were high school seniors, and followed them and their families as the youths enter emerging adulthood. the conceptual model that guided the program incorporated the following predictors: (1) autonomy-promoting parenting and responsive family relationships, characterized by developmentally appropriate instrumental and emotional support, expectations and discussions about emerging adults' roles and responsibilities, affectively positive relationships that feature open communication, and adaptive racial socialization that includes strategies for dealing with discrimination; (2) contextual stressors, including racial discrimination, poverty, and limitations in educational and occupational opportunities; (3) negative emotions and the avoidant coping responses they elicit; (4) emerging adults' future orientation, self-regulation, emotion regulation, racial identity, and sense of adult status; (5) affiliations with substance-using friends and romantic partners; and (6) cognitive antecedents of substance use, including prototypes of substance-using agemates and willingness to use substances in risk-conducive situations. to examine these constructs, the investigators implemented a multi-informant design that included assessments from emerging adults, their friends and romantic partners, their primary caregivers, and their extended family members.

Eligibility criteria:
inclusion criteria: * residence in county where sampling was targeted * youth self identified as african american or black exclusion criteria: * unable to complete survey measures or participate in intervention due to mental health concerns
an efficacy and safety study with vandetanib to treat inoperable or relapsed malignant mesothelioma

Conditions: Mesothelioma

Summary: a clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (navelbine®). in this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (navelbine®). treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. the study will recruit approximately 66 patients.


Eligibility criteria:
inclusion criteria: * diagnosed with mesothelioma * previously treated with only one course of chemotherapy for mesothelioma * no previous treatment with vinorelbine * no serious heart problems within the last 3 months exclusion criteria: * serious abnormal laboratory values * severe or uncontrolled disease or condition as judged by the investigator * pregnant or breast-feeding women * other cancers within the last 5 years * major surgery or radiation therapy within 4 weeks prior to starting study therapy * receipt of any investigational agents within 30 days prior to commencing study treatment.

Keywords: mesothelioma inoperable relapsed
health and quality of life one year after discharge from the intensive care unit (icu)

Conditions: Critically Ill

Summary: the goal is to capture the quality of life and survival of patients one year after the stay at icu. data will be collected during the stay in the icu and evaluated. one year after the icu stay patients will be send a quality of life questionnaire they need to fill out and return. all data will be evaluated together.

no detailled description necessary

Eligibility criteria:
inclusion criteria: * patients who are at least 5 days or longer without interruption at the icu exclusion criteria: * patients with less than 4 days at the icu

Keywords: qol and survival one year after icu stay
effects of periodontal therapy in patients with metabolic syndrome

Conditions: Periodontitis; Metabolic Syndrome

Summary: a 6-month, parallel-arm, investigator-masked, randomized clinical trial was conducted in patients with mets and severe periodontitis. participants were randomly assigned to an intensive periodontal treatment group (ipt; scaling and root planing and azithromycin capsules 500mg/24h/3days) or to a minimal periodontal treatment group (mpt; professional plaque removal and placebo capsules). blood and subgingival microbiological samples were collected at baseline, 3 and 6 months after therapy. the primary outcome was between-group difference in c-reactive protein (crp). secondary outcomes included hba1c, lipids, α-1 antitrypsin, fibrinogen levels and subgingival microbiota assessment.


Eligibility criteria:
inclusion criteria: * diagnosis of metabolic syndrome according to the idf definition * at least 16 teeth * at least eight sites with probing pocket depth (ppd) ≥ 6 mm and four sites with clinical attachment loss ≥ 5 mm, distributed in at least two different quadrants (koromantzos et al. 2012). exclusion criteria: * they are not medically controlled for obesity and cardiovascular risk factors at the start of the study. for ethical reasons, patient inclusion must be delayed at least 3 months when begins a pharmacological treatment. * they had history of kidney disease with cr\>1.2, ckd-epi\ 300 mg/24 hours or 0.3 mg/grcr in isolated sample. * they had history of chronic lung disease, or acute disease during the previous 3 months. * they had history of stroke during the previous 3 months, myocardial infarction or revascularization during the previous 6 months, or recent angor pectoris history. * they had history of known peripheral artery disease, or chronic heart failure. * they had surgical treatment during the previous 3 months. * they had any disease that conditions compliance along the study, such as alcoholism or psychiatric disorder. * they had a history of systemic antibiotic usage over the previous 3 months. * they had non-surgical periodontal treatment during the previous 6 months; or surgical periodontal treatment over the previous 12 months.
the ufo (ultra processed foods in obesity) project

Conditions: Obesity, Morbid; Metabolic Syndrome

Summary: the childhood obesity prevalence has increased dramatically in the last decades, affecting more than 340 million children worldwide. this condition is the major risk factor for a set of metabolic abnormalities, also known as metabolic syndrome, a condition that reduce life expectancy by 5-20 years. changes in the global food system, and the increased consumption of ultra-processed foods (upfs), may have contributed to the increase in the prevalence of childhood obesity and related morbidities. the mechanisms by which upfs might promote obesity and metabolic syndrome could be multiple and not completely identified. the ultra-processed food in obesity (ufo) project has been designed to investigate the potential associations between upfs intake and mets in pediatric subjects


Eligibility criteria:
inclusion criteria: * caucasian ethnicity, both sexes, age ≥6 and ≤18 years, diagnosis of obesity (group 1), diagnosis of obesity and metabolic syndrome (group 2), and age- and sex-matched healthy controls (group 3). exclusion criteria: * non-caucasian ethnicity; * age \ 18 years; * concomitant presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections,autoimmune diseases, chronic inflammatory bowel disease, celiac disease, metabolic-genetic diseases, cystic fibrosis and other chronic lung diseases, cardiovascular/respiratory/gastrointestinal malformations, neuropsychiatric disorders, and neurological disorders; * intake of antibiotics and/or pre/pro/synbiotics; * history of obesity surgery and onset of diarrhea or acute gastrointestinal illness during the 12 weeks prior to enrollment; * presence of tattoos, scars, moles or special lesions on both forearms.
mild, moderate and severe renal impairment study

Conditions: Gout

Summary: this is a phase 1, single-dose, open-label, pharmacokinetic (pk) and pharmacodynamic (pd) study of rdea3170 in adult male subjects with mild, moderate, and severe renal impairment.


Eligibility criteria:
inclusion criteria: * subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2. * subject with renal impairment, as determined at screening, with creatinine clearance as calculated by the cockcroft-gault formula of 60 to \< 90 ml/min (mild impairment), 30 to \< 60 ml/min (moderate impairment), or 15 to \< 30 ml/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of ≥ 90 ml/min. * subject has a screening serum urate level ≥ 4.5 mg/dl and ≤ 10 mg/dl exclusion criteria: * subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders. * subject has a history or suspicion of kidney stones. * subject has a history of asthma. * subject has undergone major surgery within 3 months prior to day 1. * subject has donated blood or experienced significant blood loss (\> 450 ml) within 12 weeks prior to day 1 or gave a plasma donation